NSCLC Clinical Trial
Official title:
A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects With Advanced or Metastatic Solid Tumors
Verified date | January 2024 |
Source | InventisBio Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a phase 1/2, open label study of D-1553 single agent treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic NSCLC with KRasG12C mutation
Status | Active, not recruiting |
Enrollment | 225 |
Est. completion date | June 30, 2024 |
Est. primary completion date | November 17, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subject with histologically proven, locally advanced, unresectable and/or metastatic NSCLC for which no standard treatment is available or the subject is refractory to or intolerant of existing standard treatment. - Subject has KRasG12C mutation in tumor tissue or other biospecimens containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used for Phase 1 subjects. Phase 2 subjects must be tested for KRasG12C mutation by a central laboratory. - Subject has measurable disease according to RECIST, v1.1 Exclusion Criteria: - Subject with unstable or progressive central nervous system (CNS) metastases. - Subjects with clinically significant cardiovascular disease - Subject with interstitial lung disease (ILD) or any active systemic infection including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. - Subject has impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption or metabolism of oral medications. - Subject is pregnant or lactating. |
Country | Name | City | State |
---|---|---|---|
China | Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences, | Hangzhou | Zhejiang |
China | Shanghai Chest Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
InventisBio Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subject incidence of Dose-limiting toxicities (DLT) | Subject incidence of Dose-limiting toxicities (DLT) | through out the DLT period, approximately 21 days | |
Primary | Number of subjects participants with adverse events | Number of subjects participants with adverse events | Through study completion, approximately 3 years | |
Primary | antitumor activity of D-1553 in subjects with advanced or metastatic NSCLC with KRASG12C mutation | Overall Response Rate (ORR, Complete Response [CR] + Partial Response [PR]) | Through study completion, approximately 3 years | |
Secondary | Plasma concentration of D-1553 | Plasma concentration of D-1553 as a single agent in subjects with advanced or metastatic NSCLC with KRas G12C mutation | approximately 6 months |
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